UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of amino acids mixture during exercise
Title of the study (Brief title)	The effects of amino acids mixture during exercise
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of amino acid mixture with placebo during exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire(VAS,RPE)
Key secondary outcomes	POMS2 Shortened version Blood glucose Lactate Free fatty acid Total ketone bodies Cortisol Amino acids Physical measurement

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test product -> Washout -> Control product
Interventions/Control_2	Control product -> Washout -> Test product
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male
Key inclusion criteria	1)Subjects who have given written informed consent 2)Healthy males aged 30 to 59 years old
Key exclusion criteria	1) Subjects with food allergies 2) Subjects having a smoking habit 3) Subjects who had blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study 4)Subjects who participated in other clinical studies within one month or are currently participating in other clinical studies 5)Subjects who are judged as ineligible by the doctor for other reasons
Target sample size	54

Research contact person
Name of lead principal investigator	Makoto Yamaguchi
Organization	Meiji Co., Ltd.
Division name	Food Science & Technology Research Labs, R&D Division
Address	1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919, Japan
TEL	042-632-5849
Email	makoto.yamaguchi@meiji.com

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	Soiken Inc.
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka 560-0082, Japan
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 24 Day
Anticipated trial start date	2018 Year 03 Month 03 Day
Last follow-up date	2018 Year 07 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 05 Day
Last modified on	2018 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035580